Isotechnika Pharma Inc IPHAF

follow up news is not good

[bromley1877]

“The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22340 and, as needed, may schedule an advisory committee meeting in the future.”

 

“At this time, the FDA has not communicated all the outstanding issues to Lux for the uveitis application,”  stated Dr. Robert Foster, President and CEO of Isotechnika Pharma.  “They await the action letter from the FDA which is expected on or near the PDUFA date of August 3, 2010 for further clarification.” 

[macbethorfaust]

note the use of the word "several"F**k, can't these guys get anything right?  They have a priority review i.e. constant communication and less than a week before the meeting they have "outsanding issues"?  And not just one but "several".Like I said, nincompoops.

[macbethorfaust]

Translation: “The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled[NOT POSTPONED, CANCELLED]. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to

[BornReady1970]

.20 I think would be on the high side. At best, we will only be delayed 3-6 months. The problem, we don't have the cash to make it through a six month delay. If the FDA ask for anything that requires $$$ in the way of studies or lab time, then that is just more $$$ that we don't have and shortens the runway even more.The last time ISA lenghtend the runway it cost 25-30% of the company

[WASKERWISK]

Lux is paying for the NDA application so I’m not worried about the extra expense. But I am worried about ISA keeping the doors open for long enough to get the milestone. I’m not saying this happened (although it is easy to be paranoid here) if you had some Machiavellian types at Lux (say, for example, former Roche execs) and you had conduct of the approval process and you knew that delay

[Investandpray]

  Very good points Waserwisk. Why does the FDA seem so clueless here?? Didn't they get 1 million pieces of paper with data when Lux filed and this still is not enough? How they worded their message made it sound like they are dealing with amateurs. Keep in mind Lux is also at fault here not just ISA. Lux conducted all the trials for this application. Lux is mostly to blame here IMO

[teevee]

Waskerwisk,It appears to be  in Paladin's  best interests if ISA were to "go away" as, if ISA were to go under, I doubt any partnership agreements would survive the bankruptcy as Paladin retains the IP. Assuming there is some real value to ISA's licences from Paladin, and that Lux's NDA has a real chance of success, considering the ongoing delays may now jeopardize